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Completed

NCT Number: NCT01213173

Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients

The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®) (95 - 190 mg) on heart rate in the Stable angina patients.

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Key information

Conditions

Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of informed consent prior to any study specific procedures
  • Chinese patients
  • Heart rate ≥ 65bpm
  • Has been diagnosed as Stable angina for at least 1 month and with stable angina pectoris symptoms within 2 weeks previous to enrolment(Please find the diagnose criteria of Stable angina on Appendix C)
  • With Left ventricular ejection fraction ≥ 50% according to ultrasound cardiogram;
  • Has been on beta-blockers for at least 4 weeks*, on the dose equivalent to Betaloc ZOK® 23.75-47.5mg/day.

Exclusion criteria

  • Acute myocardial infarction within 6 months
  • Unstable angina or Prinzmetal's angina
  • II degree of AV block or greater
  • Significant clinical, laboratory or electrocardiographic abnormalities that would place the subject at undue risk (in the Investigator's opinion) including:
  • Significant renal impairment (serum creatinine > 2.0 mg/dL)
  • Serum Alanine Aminotransferase or Aspartate Aminotransferase > 3 x upper limit of reference range
  • Serum potassium < 3.0 mEq/L
  • Serum sodium ≤ 130 mEq/L
  • Acute or chronic hepatitis or cirrhosis (clinical diagnosis)
  • Uncontrolled hyperthyroidism (clinical diagnosis)
  • Systolic blood pressure ≥ 180 mmHg, or < 100mmHg at enrolment
  • Patients with unstable, not compensated heart failure (pulmonary oedema, hypoperfusion or hypotension)

Treatment and study plan

Succinate Metoprolol (Betaloc ZOK®)

Drug

treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks

Primary outcomes

  1. The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)

    Time frame: After 8 weeks treatment in the study

    Difference of the 24-hr average heart rate between two groups after 8 weeks treatment.

Secondary outcomes

  1. The Impact on 24-hr Average Heart Rate From Baseline Within Groups

    Time frame: After 8 weeks treatment in the study

    Difference of the 24-hr average heart rate within groups from baseline after 8 weeks treatment.

  2. The Different Impact on 24-hr Average Heart Rate Between Two Groups

    Time frame: After 2 weeks treatment in the study

    Difference of the 24-hr average heart rate between two groups after 2 weeks of treatment.

  3. The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups

    Time frame: After 2 weeks treatment in the study

    Difference of the 24-hr average heart rate within groups from baseline after 2 weeks treatment.

  4. The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups

    Time frame: After 2 weeks treatment

    Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 2 weeks treatment between groups

  5. The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups

    Time frame: After 8 weeks treatment

    Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 8 weeks treatment between groups

  6. The Difference of Change From Baseline in Total Ischemic Burden Between Groups

    Time frame: After 2 weeks treatment

    Difference in change from baseline in TIB between two groups after 2 weeks treatment.

    Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc).

  7. The Difference of Change From Baseline in Total Ischemic Burden Between Groups

    Time frame: After 8 weeks treatment

    Difference in change from baseline in TIB between two groups after 8 weeks treatment.

    Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc).

  8. The Difference of Change From Baseline in Angina Frequency Between Groups

    Time frame: After 2 weeks treatment

    Difference in change from baseline of angina pectoris frequency between two groups after 2 weeks treatment.

  9. The Difference of Change From Baseline in Angina Frequency Between Groups

    Time frame: After 8 weeks treatment

    Difference in change from baseline of angina pectoris frequency between two groups after 8 weeks treatment.

  10. The Change From Baseline in Total Cholesterol

    Time frame: After 8 weeks treatment

    Difference of change from baseline in TC after 8 weeks treatment between groups.

  11. The Change From Baseline in Fasting Plasma Glucose

    Time frame: After 8 weeks treatment

    Difference of change from baseline in FPG after 8 weeks treatment between groups.

  12. The Change From Baseline in Triglycerides

    Time frame: After 8 weeks treatment

    Difference of change from baseline in TG after 8 weeks treatment between groups.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Open Label, Parallel Group, Multicentre, Phase IV Study on the Effect of 8 Weeks Succinate Metoprolol (Betaloc ZOK®) (95 - 190 mg) on Heart Rate in the Stable Angina Patients

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 1, 2010
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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